Dietetic Effects of Mare's Milk in Patients With Chronic Inflammatory Bowel Diseases (IBD) - a Double Blind Placebo Controlled Cross-over Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 4
- 主要终点
- Score of Crohn´s Disease and/or Ulcerative Colitis
研究概览
简要总结
Mare's milk consumption could improve the well-being in patients with Crohn's disease and ulcerative colitis, respectively.
详细描述
Background: Dietetic effects of mare's milk have been reported for a long time and can be based on bactericidal and immunological components of mare's milk.
Objective
Dietetic effects of oral intake of mare's milk in adolescent patients with chronic inflammatory bowel diseases were investigated.
Design: In a randomized, placebo-controlled, double-blind, cross-over intervention study, eight Crohn's disease patients and nine ulcerative colitis patients received daily 250 mL mare's milk or placebo drink.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clear and definite diagnosis of ulcerative colitis and Crohn's disease resp.
排除标准
- •lactose intolerance and pregnancy
结局指标
主要结局
Score of Crohn´s Disease and/or Ulcerative Colitis
时间窗: 8 weeks
score for Crohn´s disease: Crohn´s Disease Activity Index (CDAI), \< 150 = remission, 151-220 = moderate activity, 221-450 = severe activity; score for ulcerative colitis: Colitis Activity Index (CAI), 0-4 = remission, 5-9 = low activity, 10-16 = moderate activity, 17-23 = high activity.
次要结局
- Extra-intestinal Pain(8 weeks)
研究者
Gerhard Jahreis
Prof. Dr.
University of Jena